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Details for New Drug Application (NDA): 200327

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NDA 200327 describes TEFLARO, which is a drug marketed by Cerexa and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TEFLARO profile page.

The generic ingredient in TEFLARO is ceftaroline fosamil. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ceftaroline fosamil profile page.

Summary for NDA: 200327

ceftaroline fosamil

Pharmacology for NDA: 200327


Suppliers and Packaging for NDA: 200327

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ceftaroline fosamil
POWDER;IV (INFUSION) 200327 NDA Forest Laboratories, Inc. 0456-0400 0456-0400-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0400-10) > 20 mL in 1 VIAL, SINGLE-DOSE (0456-0400-01)
ceftaroline fosamil
POWDER;IV (INFUSION) 200327 NDA Forest Laboratories, Inc. 0456-0600 0456-0600-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0600-10) > 20 mL in 1 VIAL, SINGLE-DOSE (0456-0600-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION)Strength400MG/VIAL
Approval Date:Oct 29, 2010TE:RLD:No
Patent:6,906,055Patent Expiration:Dec 15, 2021Product Flag?YSubstance Flag?YDelist Request?
Patent:7,419,973Patent Expiration:Dec 15, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:8,247,400Patent Expiration:Feb 10, 2031Product Flag?YSubstance Flag?Delist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.